Prevalence of Lactose Intolerance Following Stem Cell Transplantation

This study has been terminated.
(Too few patients completed the study once enrolled.)
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00247806
First received: October 31, 2005
Last updated: September 24, 2008
Last verified: October 2005
  Purpose

It is currently assumed that all patients are lactose intolerant post bone marrow transplantation. This pilot study is to assess what the incidence of lactose intolerance is after bone marrow transplantation in children. This will be done using a lactose breath test.


Condition Phase
Lactose Intolerance
Phase 1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prevalence of Lactose Intolerance Following Stem Cell Transplantation in Pediatric Patients.

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Estimated Enrollment: 20
Study Start Date: October 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

All pediatric patients over the age of 4 years who are scheduled for a stem cell transplant will be approached to assess whether what the incidence of lactose intolerance is in the post transplant period and how quickly recovery occurs. A baseline lactose and lactulose breath test will be performed followed by repeat lactose breath tests starting 2 weeks after day 0 and repeated every fortnight for 10 weeks. Stool pH and reducing substances will be checked at the time of the breath tests to see if there is any correlation.

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients planned to undergo a stem cell transplant.

Exclusion Criteria:

  • Refusal to participate
  • Unable to perform breath tests on request (generally under the age of 4 years.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247806

Locations
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Colin Barker, PhD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Colin C Barker, University of British Columbia
ClinicalTrials.gov Identifier: NCT00247806     History of Changes
Other Study ID Numbers: C05-0180
Study First Received: October 31, 2005
Last Updated: September 24, 2008
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Pilot, pediatric, stem cell transplant, lactose intolerance

Additional relevant MeSH terms:
Lactose Intolerance
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on July 23, 2014